Antengen IND application in China: Phase 3 study of ATG-010 (selinexor) in advanced or recurrent endometrial cancer

Antengen IND application in China: Phase 3 study of ATG-010 (selinexor) in advanced or recurrent endometrial cancer

Upcoming study of another biological molecular targeting strategy, novel compared to many.  United States centers for this study should become available as this is an international study.

SHANGHAI and HONG KONG, January 4, 2021 / PRNewswire / – Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to the discovery, development and commercialization of world-class and / or world-class therapeutics in hematology and oncology, announced that that it has filed an Investigational New Drug (IND) application with the National Medical Products Administration (NMPA) for ATG-010 (Selinexor) for the treatment of endometrial cancer. This is a Phase 3, multicentre, double-blind, randomized, global study (SIENDO) aimed at evaluating the effectiveness of ATG-010 versus placebo as maintenance therapy in patients with advanced or recurrent endometrial cancer after combination chemotherapy 80 investigative agencies around the world, underneath North America, Europe and Asia.

ATG-010 is a premier and only oral selective inhibitor of nuclear export developed by Antengene and Karyopharm Therapeutics Inc. (NASDAQ: KPTI). It has been approved by the US Food and Drug Administration (FDA) for use in both multiple myeloma and diffuse large B-cell lymphoma, which are two main indications for hematological malignancies. In addition, the Phase 3 SIENDO study of ATG-010 in patients with endometrial cancer passed the planned preliminary futility analysis and the Data and Safety Monitoring Board (DSMB) recommended that the study continue as planned without changes.

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“I help and guide women to defeat gynecologic cancers and advanced pelvic conditions such as endometriosis, using a unique combination of minimally invasive robotic surgery, precision medicine therapies and complementary holistic natural support towards thriving in survivorship." Dr. Vasilev is the only physician quadruple board certified in Ob-Gyn, Gynecologic Oncology and Integrative & Holistic Medicine in the United States. He is an accomplished advanced robotic surgeon and serves as Medical Director of Integrative Medicine and Integrative Gynecologic Oncology at Providence Saint John's Health Center, Professor at John Wayne Cancer Institute in Santa Monica, California and is Clinical Professor at Loma Linda University School of Medicine. He is former faculty and professor at UC Irvine, UCLA, USC and City of Hope. He is an active member of multiple medical societies and has been nationally listed in "Best Doctors" for 18 years.